Why ISO for Aigenpulse?

Our press release is here, but before you read that, we thought it would be useful to understand exactly why and how we undertook this journey into achieving internationally recognised standards.

Our Quality Story

“Trust, Respect, Diversity” – Aigenpulse’s Core Values

This was our motto when we started to develop our Business Management System in early 2018. We had the idea of ‘continuous compliance’ whereby we were audit-ready at all times – adding tremendous value to the quality we deliver to our customers. This relied heavily on automating the generation of compliance documentation from the software build and test processes. For this initiative to be successful, it was only possible by living our core values.

Trust

Our Integrated Management System Handbook

Trust and faith in the workforce make the team’s job easier. The team makes decisions faster and revise them less often.

Developing the Business Management System, i.e. our handbook of processes and policies, here at Aigenpulse, was an interesting project and a nice example of showing trust.

From the very beginning, every team was empowered to start the development of their own processes using a company-wide open platform. Everyone in the company was able to review the proposed processes and were able to suggest changes. As a rule, all comments had to be addressed and any process change was immediately available to all employees. We developed our own Handbook of Processes in less than 9 months – it’s a living document which is accessible by all. 

Respect

“Transparency breeds respect and respect breeds success”

One of our initial aspirations was the creation of an open working environment. Information to flow freely and team members to have access to the resources they needed to get work done.

For this reason, we started to use tools that allowed us work in a more open and connected way. We started to make knowledge more accessible within and across the teams. Alternative viewpoints were allowed to be expressed during code and design review enabling constructive discussions to take place. This is possible due to the core expectation of respectful conversations between every Aigenpulse employee, especially important during conversations with opposing viewpoints – no one’s views are silenced, everyone is expected to listen and be listened to. Above all sound logic and reasoning always prevails.

Diversity

Our Integrated Management System

“In every team, there is a voice of quality”

From very early on, we felt that to get the most out of the quality assurance function it shouldn’t be isolated within a single team. Instead, we have assigned a ‘voice of quality’ in every team meaning that every member is empowered and entrusted to perform their duties with quality at the forefront of their activities. In addition, we promote cross-fertilisation of ideas by inviting people from other teams to see what quality means in the different business functions.

The outcome of this created genuine opportunities for improvements which were developed and implemented in different teams. For instance, continuous compliance progressively was developed within and by the Software Development Team. This enabled us to achieve compliance and audit readiness but was championed by the Team – it was not detrimental to their work, in fact, they’ve found it to be a positive experience because the focus on quality has enabled them to become more improved programmers.

For instance, influences from the Software Development team have been implemented across the company, such as using Gitlab to handle appraisal and approval of process documentation. All our staff (including non-technical) were provided training to be able to contribute and comment on the documentation – something our non-techies find intuitive and easy-to-do!

And we are not done yet!

Our compliance journey has just formally started with the certification of ISO 9001:2015 ISO 27001:2013, but this is only the beginning. We’re developing our processes further to align with GAMP5/GxP and other ISO accreditations – so watch this space!

As our business will grow and change, and our culture will evolve too. And that’s ok. But our core values will remain steady.